View clinical trials related to Chronic Disease.
Filter by:The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.
The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas. The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention. Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.
Pneumonia remains an important cause of morbidity and mortality in older adults with obstructive lung disease. Risk factors for pneumonia, including episodes associated with a hospital admission, have been extensively characterized in clinical trials and observational studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior COPD exacerbations, dyspnea , normal to low body mass index (<25), current smoking and certain co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has also been identified, as associated with an increased risk of pneumonia in patients with COPD. The primary objective of this study is to estimate the magnitude of known risk factors and the outcomes of pneumonia requiring hospitalization and the potential effect modification of these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as community-acquired pneumonia (CAP) resulting in hospitalization and/or death and hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary endpoint, CAP that did not result in hospitalization or death will be examined. As a secondary objective, we will describe characteristics for those patients who develop pneumonia requiring hospitalization compared to those with pneumonia not requiring admission. This study will use the General Practice Online Database (GOLD), formerly referred to as the General Practice research Database (GPRD), a primary care electronic medical record database. A new user cohort will be defined among patients with COPD who are 45 years and older in the United Kingdom. Patients will be considered a new user of ICS-containing medications if they had not received a prescription for an ICS-containing medication in the prior year. The comparator treatment group will be new users of long-acting bronchodilators (LABD), including long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one year washout period, all new users could not have either ICS-containing medications or LABD. Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the number of pneumonia events and the number of new users separately to examine the available precision based on the study design. Patients will be followed from the date of their first eligible prescription (Cohort Entry Date) until the earliest of the following: date of study end point (first pneumonia event of interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of transfer to a new practice, date of ICS initiation (among LABD new users), death or study end (end of available data). As part of the primary analysis, patients will be examined for their first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe CAP will be examined. Incidence rates of the pneumonia outcomes will be calculated as the number of patients experiencing an event divided by the person-years at risk. Multivariable analysis will be performed using Cox proportional hazard model with adjustment for confounders and medication exposure. To adjust for differences confounding by severity due to differences in prescribing between ICS-containing medications and LABD, propensity scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The propensity score will be estimated to model the probability of a patient receiving ICS-containing medication prescription versus receiving a LABD prescription given a patient's observed set of baseline covariates. Effect modification (statistical interaction) will be evaluated based on available theory and include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI ≥25, age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current smoking status, social deprivation quartiles). Additional interactions may be evaluated. To test proportionality of the hazard functions, model diagnostics will be performed. To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess differences between treatments, clinical and patient characteristics will be compared using the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively. Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs. HAP. Additional analysis or adjustments to the analytic or modeling strategy will be performed if the data warrants. A more detailed modeling strategy, including generation of the propensity scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a priori plan will be described in the final study report.
GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of inflammatory airway diseases. GSK2269557 has already been administered as a nebulized solution in single and repeat doses to humans and has been well tolerated across the range of doses used. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study is the first administration of dry powder GSK2269557 in humans. Part A will consist of four treatment periods separated by at least 14 days wash out periods. In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500 mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed before each dose escalation. Part B will be a parallel group design conducted in a separate group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3 subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the same as the dose that was well tolerated in Part A. The study duration, including screening and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for subjects in part B of the study.
The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan.
This study is the First Time in Human Study for GSK2256294 and will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK2256294 administered to healthy male volunteers (Cohort 1) and otherwise healthy adult male moderately obese smokers (Cohorts 2 to 4). Cohorts 1 and 2 will enrol 12 subjects each and each subject will take part in four study periods. All subjects will receive placebo regimen and three dosing regimens of GSK2256294 in a specified sequence (planned doses 2 mg, 6 mg and 18 mg in Cohort 1 and 15 mg, 40 mg and 100 mg in Cohort 2). Each study period will be followed by a Wash-out period of 7 to 14 days in Cohort 1 and up to 4 weeks in Cohort 2. During each study period subjects will be in-house from Day -1 until the 48 hours post dose assessments have been completed. Subjects will return to the unit as out-patients for remaining post-dose assessments. Subjects will then be followed for 7 to 14 days in Cohort 1 and up to 3 to 4 weeks in Cohort 2. Total duration of the study for Cohort 1 will be 98 days and for Cohort 2 it will be up to 144 days. Cohort 3 and 4 will each recruit 15 subjects. For Cohorts 3 and 4, each subject will take part in one treatment period of 18 days (Day-1 to Day 17) with dosing from Day 1 to Day 14. Subjects will then be followed for 7 to 14 days. Total duration of the study for Cohort 3 and Cohort 4 will be 67 days. Dose selection for Cohorts 3 and 4 will be based on the safety, PK profile and enzyme inhibition obtained in Cohorts 1 and 2. This study will also evaluate the evidence for a functional effect of soluble Epoxide Hydrolase (sEH) in a forearm blood flow (FBF) model.
The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.